Justices Strike Down Gene Patents

WASHINGTON—The Supreme Court unanimously held Thursday that human genes cannot be patented, even when isolated from the body, a ruling expected to quickly expand access to genetic testing while potentially allowing inventors to retain rights to artificially created DNA.

The decision marked the latest step in the court's decadelong march to toughen the requirements for patents. The justices repeatedly have declared that 21st-century innovation depends less on locking up intellectual-property rights than on expanding access to discoveries in order to spur further progress.

The case involved two genes, known as BRCA1 and BRCA2, where mutations can indicate significant likelihood of breast and ovarian cancer.

The Supreme Court unanimously ruled that human genes isolated from the body can't be patented, a victory for doctors and patients who argued that such patents interfere with scientific research and the practice of medicine. Jess Bravin reports.

Three weighty issues -- voting rights, affirmative action and gay marriage -- are awaiting resolution by the High Court. They likely will be decided in a hectic final week of June. Here is a primer on the cases.

Ruling

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The Salt Lake City company that isolated those genes, Myriad Genetics Inc.,MYGN1.44% patented them and enforced its monopoly to control the market in genetic testing for the propensity to develop those cancers. The actress Angelina Jolie recently thrust genetic testing into the spotlight when she disclosed that she possessed the cancer-associated mutation, prompting her to undergo a double mastectomy.

At issue was whether the genes, when isolated from the chromosomes in which they reside, are an invention, and therefore eligible for a patent, or a product of nature, which, regardless of the effort or expense involved in its discovery, cannot be patented.

In an opinion written by Justice Clarence Thomas, the court followed the blueprint laid out by Solicitor General Donald Verrilli, rejecting the views of both the U.S. Patent and Trademark Office and the specialized tribunal that hears patent appeals, the U.S. Court of Appeals for the Federal Circuit.

Justice Thomas credited Myriad for a "medical breakthrough" in identifying and isolating BRCA1 and BRCA2, which can foretell a 50% to 80% likelihood of breast cancer, compared with the average American woman's 12% to 13% risk.

But, he continued, "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy" federal law's requirements for a patent. In 1948, he observed, the court found unpatentable a product that combined several bacteria useful in improving soil-nitrogen levels, because the bacteria themselves were naturally occurring.

Likewise, Justice Thomas wrote, "separating (a) gene from its surrounding genetic material is not an act of invention." And far from promoting innovation, as the company and its industry allies argued, allowing its patent to stand would frustrate progress.

ENLARGE

The decision should have "an immediate impact" on public health, allowing rival companies and laboratories to enter the market on genetic testing, said Harry Ostrer, a physician at Yeshiva University's Albert Einstein College of Medicine in Bronx, N.Y. Researchers including Dr. Ostrer, as well as medical groups and patients, challenged Myriad's patents and were represented by the American Civil Liberties Union.

"Costs should come down considerably," and greater competition should "improve the quality of genetic testing overall," said Dr. Ostrer.

Myriad, in a statement, stressed the patent claims the court didn't invalidate, particularly for synthetic, or complementary, DNA created through gene splicing and known as cDNA.

Myriad charges $3,340 for its genetic test, which accounted for more than 80% of the company's $496 million revenue last year.

Medical companies on Thursday were quick to announce plans for products testing for genes linked to breast and ovarian cancer after the decision.

Beyond BRCA1 and BRCA2, Dr. Ostrer said the Supreme Court decision could invalidate patents for as many as 4,000 isolated genes, including ones that can help forecast the propensity for birth defects and heart conditions.

The director of the National Institutes of Health, Francis Collins, said the ruling will make it easier to develop new combinations of tests and therapies "tailored to each person's unique genetic makeup."

The Supreme Court long has held that "laws of nature, natural phenomena, and abstract ideas are not patentable," Justice Thomas wrote, for they are not themselves innovation, but rather the "basic tools of scientific and technological work."

Allowing a company to tie up the building blocks of nature "would be at odds with the very point of patents, which exist to promote creation," Justice Thomas wrote.

The court foreshadowed Thursday's decision in a March 2012 unanimous ruling that threw out two medical-testing patents and overruled the same specialized appeals court that had favored gene patents. Justice Stephen Breyer wrote at the time that the medical-test patents merely recited laws of nature and walked doctors through obvious steps.

In Thursday's opinion, the court gave Myriad a small consolation prize by finding in favor of the patentability of cDNA, which typically is used for genetic engineering. "The lab technician unquestionably creates something new when cDNA is made," Justice Thomas wrote, with novelty among the essential elements of patentability.

Still, a footnote gave Myriad little reason to cheer. Justice Thomas added that the court took no position on whether cDNA met the other requirements for a patent, such as being "nonobvious." He referred to a brief filed by the Obama administration, which observed that "given the prevailing level of knowledge in biotechnological fields, future patent applications directed to cDNAs and other synthesized DNA molecules may be rejected as obvious."

Myriad shares initially rose sharply on the ruling but ended the day down 5.6% at $32.01 as investors reconsidered the odds that the cDNA ruling would help the company.

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